Fibromyalgia is believed to be one of the most common causes of chronic pain that is suffered today. Accurate numbers, however, are quite difficult to determine because of the difficulty in diagnosing the disorder and because the experts often differ in how they define the disorder. This is in part due to the fact that Fibromyalgia is a syndrome rather than a disease. Diseases have known causes and work by well known mechanisms, while syndromes are defined by a patient having a set of signs or symptoms. Examples of other syndromes are rheumatoid arthritis and lupus. The risk of diagnosing patients by such methods is that patients with different diseases that should be treated by different approaches may be lumped into the same syndrome and some patients may not be diagnosed as having a syndrome when they are suffering from the same disorder. One common method of diagnosing fibromyalgia is by testing a patient experiencing chronic pain by applying firm pressure at eighteen specified “tender points.” Patients with tenderness at eleven of such tender points are diagnosed as having fibromyalgia.
Due to the confusion in the field, there has been little progress toward development of a true cure because no single cause has been identified. There are various treatments that typically are designed to address the symptoms of fibromyalgia—the chronic pain—and the side effects brought on by the symptoms such as severe fatigue, insomnia, diarrhea, abdominal bloating, bladder irritation, headaches, etc., but no treatment has been developed that treats the underlying cause of fibromyalgia. However, true fibromyalgia, as it relates to the present invention, is caused by the build-up of fibrotic material in the soft tissue due to fibrin precipitation. This fibrin precipitation causes the chronic pain which in turn causes the side effects. Thus, there is a need for compositions and methods that treat the underlying cause of fibromyalgia by treating the condition that leads to the build up of fibrotic material.
In addition to fibromyalgia, several other disorders are characterized by a deposition of fibrotic material in the soft tissue. Thus a treatment that attacks the cause of fibromyalgia will also be effective in treating such other disorders. Thus there is a broader need for methods of treating diseases and disorders characterized by a fibrotic condition in a patient, especially fibromyalgia.